NDMA: What Is it and Why Should I Be Concerned?

Many lots of the drug Valsartan were recalled last year due to the contamination of n-nitrosodimethylamine (NDMA), a known animal carcinogen and a probable human carcinogen. More recently, a number of manufacturers recalled their Zantac and ranitidine products due to the belief that the drugs can naturally produce high levels of NDMA as a byproduct of the digestion process.  Many individuals don’t know what NDMA is or how it can impact their health and lifestyle. Here we’ll explore what it is and why the recall was necessary.

Do I Have a Zantac Case?

Do I Have a Valsartan Case?

What Is NDMA?

NDMA is a semi-volatile organic chemical that can form naturally or unintentionally through industrial processes. Unintentional NDMA can form as a byproduct of the chlorination of wastewater and drinking water. This process led NDMA to be found in Valsartan tablets produced by four different facilities:  Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited in India, Aurobindo Pharma in India, and Mylan Laboratories, Ltd. in India.

NDMA can also be formed through natural processes. Ranitidine, the active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA once it is ingested. Specifically, the ranitidine compound contains the two elements that are required to form NDMA: nitrite (“N”) and dimethylamine (“DMA”). The presence of both nitrite and dimethylamine in ranitidine’s chemical structure renders it highly capable of producing NDMA under the right conditions.

A recent independent study conducted by Valisure Online Pharmacy sought to understand how capable ranitidine was of naturally producing NDMA. During the testing, Valisure simulated the conditions that ranitidine is exposed to in the human stomach to see how the ranitidine would react; namely, they mixed ranitidine with the gastric fluid and sodium nitrites that stimulate the digestion process. They found that when the ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA are produced. In fact, when exposed to the simulated stomach conditions, the ranitidine produced approximately 304,500 nanograms (ng) of NDMA per tablet. This is an alarming amount of NDMA, considering the FDA-approved acceptable amount of NDMA intake is 96 ng per day.

Concerns about the molecular generation of NDMA associated with ranitidine have led to several recalls of ranitidine products.

In September 2019, there were voluntary recalls by Sandoz, Inc. and Apotex Corp. The Sandoz ranitidine recall involves 14 lots of prescription capsules, while the Apotex ranitidine recall involves all of its 75mg and 150mg over-the-counter capsules. Many of the Apotex capsules were labeled and sold by popular pharmacies Walgreens, Wal-Mart, and Rite-Aid.

In October 2019, numerous additional voluntary recalls have been announced. On October 23rd, it was announced the Dr. Reddy’s Laboratories Ltd and Sanofi would be recalling ranitidine products. The Dr. Reddy’s recall involves all prescription and over-the-counter capsules manufactured by the company, while Sanofi issued a recall of its over-the-counter ranitidine. On October 28th, it was announced that Perrigo Company, Novitium Pharma LLC, and Lannett Company, Inc. would be recalling ranitidine products as well due to the presence of NDMA. Perrigo Company is recalling all over-the- counter ranitidine tablets; Novitium Pharma is recalling all ranitidine hydrochloride capsules; and, the Lannett Company recall involves all lots of prescription ranitidine syrup.

While several recalls have already occurred, several other countries, including Canada, have taken further action by ordering complete recalls of all Zantac and ranitidine products.

In December 2019, the regulators for multiple global health organizations began testing samples of the type 2 diabetes drug metformin for NDMA contamination. As of December 5, 2019, there has been no metformin recall in the United States. The FDA said in a statement that it has not confirmed any NDMA contamination of metformin sold in the United States, but that any contamination detected beyond the acceptable daily intake limit will lead to recommended recalls. Singapore’s Health Sciences Authority announced on December 4 that is was recalling three metformin medications due NDMA contamination.

Metformin is manufactured as a generic by multiple global pharmaceutical companies. Popular brand name drugs sold in the United States that contain metformin include Fortamet, Glucophage, Glucophage XR, Glumetza, and Riomet.

What Are the Effects?

NDMA can contaminate drinking water and humans often get NDMA exposure from consuming food or drink that was contaminated with NDMA. Exposure to NDMA in Valsartan can cause prostate cancer, lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. Even small amounts of exposure can lead to liver damage. Exposure to NDMA in ranitidine has been linked to a number of cancers including stomach cancer, cancer in the small and large intestines, colorectal cancer, esophageal cancer, kidney cancer, bladder cancer, liver cancer, prostate cancer, pancreatic cancer, leukemia, non-hodgkin’s lymphoma, and multiple myeloma.

Classified as a Carcinogen

The EPA classifies NDMA as a B2 carcinogen, meaning it is a probable human carcinogen. B2 carcinogens do not have enough human data but have a sufficient amount of animal data to conclude that it’s a potential carcinogen. Many animal studies were done to test NDMA, and they found that various species, including rats and mice, developed tumors in the liver, respiratory tract, and blood vessels after exposure to NDMA. The U.S. Department of Health and Human Services believes that NDMA is “reasonably anticipated to be a human carcinogen.”

Contact GoldenbergLaw

If you or a loved one contracted cancer after taking Valsartan, ranitidine, or metformin, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability.

What You Should Know About The FDA Recall of Zantac

The Food and Drug Administration (FDA) continues to announce recalls of the popular heartburn medication Zantac and its generic formulation ranitidine due to contamination with the known carcinogen N-Nitrosodimethylamine (NDMA). The latest announcements of five additional Zantac and ranitidine recalls come a month after the agency announced initial recalls by Sandoz and Apotex and alerted the public that NDMA had been found in samples of ranitidine. These recalls include both prescription and over-the-counter Zantac.

Do I Have A Case?

Zantac has been on the market for over thirty years and millions of people have taken these medications. For anyone currently taking these drugs, you should immediately contact your doctor to discuss your options.

Zantac Recall Summary

Precision Dose Ranitidine Recall

On November 19, 2019, repackaging company Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution–USP 150mg/ 10mL from the market. The ranitidine product is being recalled due to potential NDMA presence above the standards approved by the Food and Drug Administration.

The recall was initiated after manufacturer Amneal Pharmaceuticals, LLC) issued a voluntary recall which included lots repackaged by Precision Dose Inc.

Golden State Ranitidine Recall

On November 15, 2019, repackaging company Golden State Medical Supply, Incorporated (GSMS, Inc.) voluntarily recalled all quantities and lots of Ranitidine HCl 150mg and 300mg capsules due to the potential presence of NDMA above levels approved by the Food and Drug Administration.

The voluntary recall comes after GSMS, Inc received a recall notice from manufacturer Novitium on October 25, 2019 and initially recalled 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg capsules on November 6, 2019.

American Health Ranitidine Recall

On November 8, 2019, American Health Packaging voluntarily recalled 8 lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150mg/10mL Liquid Unit Dose Cups from the consumer market due to an “unexpected impurity” of NDMA detected in the finished products at levels deemed unsafe by the Food and Drug Administration.

The recall comes in response to manufacturer Lannett Company, Inc.’s voluntary recall of ranitidine products which included affected lots that were repackaged by American Health Packaging.

Amneal Ranitidine Recall

On November 8, 2019, Amneal Pharmaceuticals, LLC voluntarily recalled Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that were distributed directly to wholesalers, distributors, retailers, and re-packagers due to potential NDMA levels deemed unacceptable by Food and Drug Administration standards.

Lannett Ranitidine Recall

On October 28, 2019 the FDA announced that Lannett Company, Inc. recalled all lots of its prescription ranitidine syrup. The recall includes Lannett’s ranitidine oral solution prescribed in 15mg/mL doses due to the confirmed presence of NDMA.

Novitium Pharma Ranitidine Recall

On October 25, 2019, the FDA confirmed that Novitium Pharma LLC recalled all lots of its over-the-counter Ranitidine Hydrochloride capsules in the United States. Novitium’s ranitidine recall includes all lots of 150 mg and 300 mg dosages sold in 30, 60, 100, and 500 count bottles. The FDA announcement states that the recall was due to potential unsafe levels of NDMA found in the capsules.

Perrigo Ranitidine Recall

On October 23, 2019, the FDA announced that Perrigo Company plc issued a worldwide recall of all lots of its over-the-counter ranitidine products. The announcement states that Perrigo halted shipments of its ranitidine products on October 8 due to the possible presence of NDMA. The Perrigo recall includes many popular ranitidine products, including the Publix over-the-counter store brand.

Dr. Reddy’s Ranitidine Recall

On October 23, 2019, the FDA announced that Dr. Reddy’s Laboratories, LTD. issued a voluntary recall of all lots of its ranitidine products – both prescription and over-the-counter – sold in the United States on October 1. This recall includes lots of ranitidine sold under store brand names at Walgreens, Target, Walmart, Kroger, and CVS. The ranitidine recall was initiated after product testing confirmed unsafe levels of NDMA. For a full list of products recalled under the Dr. Reddy’s ranitidine recall, visit the FDA recall page.

zantac-pill-containersSanofi Zantac OTC Recall

The FDA also confirmed on October 23, 2019 that Sanofi recalled all lots of its Zantac OTC (over-the-counter) medications sold in the United States and Canada on October 18. The company cited “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” as the reason for the recall. The Sanofi Zantac OTC recall includes all lots of Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

Apotex Ranitidine Recall

On September 25, 2019, the FDA announced that Apotex Corp. voluntarily recalled its over-the-counter Ranitidine Hydrochloride tablets on a precautionary basis due to concerns of NDMA contamination. The Apotex ranitidine recall applied to 75 mg and 150 mg tablets sold under store brand names at Rite Aid, Walmart, and Walgreens pharmacies.

Sandoz Ranitidine Recall

On September 23, 2019, the FDA announced that Sandoz Inc. recalled all lots of its Ranitidine Hydrochloride capsules sold over-the-counter in the United States due to confirmed NDMA contamination. Sandoz is a subsidiary of the Swiss pharmaceutical conglomerate Novartis. The Sandoz ranitidine recall applies to 14 lots of Ranitidine 150 mg and 300 mg capsules sold in 30, 60, and 500 count bottles.

What Is Zantac?

Zantac is a medication that limits the production of stomach acid and belongs to a class of medications known as H2 blockers. It is sold as a generic under the name of its active ingredient, ranitidine. Zantac is sold over-the-counter to treat heartburn and acid indigestion, and prescribed for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease, and certain stomach and esophagus conditions.

What Is NDMA?

NDMA is classified as a probable human carcinogen that can form as a byproduct of industrial processes or, as in Zantac, from a reaction with the body. The chemical can be found in small quantities in drinking water but in levels that are considered generally harmless. The NDMA found in the recalled Zantac and ranitidine products is above levels considered safe by the FDA. NDMA had previously been found in the blood pressure medication Valsartan, which prompted a string of product recalls starting in July 2018.

NDMA exposure in Zantac and ranitidine has been linked to digestive system cancers such as:

  • Stomach cancer
  • Intestinal cancer (both of the small and large intestines)
  • Esophageal cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Bladder cancer
  • Stomach cancer
  • Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer

Additionally, in babies born to mothers who took Zantac consistently throughout their pregnancies, NDMA has been linked to cancers, including brain cancers, in young children.

How We Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.

Juul Is Officially Not Cool

All PR is good PR, unless you’re Juul right now. With appearances across international news broadcasts, popular YouTubers’ channels and even on TikTok (the newest social media platform loved by teens), the perils of Juul have become widespread knowledge, exposing the company’s unethical development practices and marketing tactics. 

A recent Reuters investigation concluded that the company has been entrenched in controversial developments from its early stages. A former employee has disclosed that discussions around the product’s potency and addictiveness were debated initially, however any employee concerns about product safety took a backseat to the company’s exponential growth. What’s become clear is the true effects of Juul are surfacing through numerous studies investigating the potency and addictiveness of the product, particularly amongst teenage users. 

Juul Delivers More Nicotine than Most Cigarettes

In a new study out of Penn State University College of Medicine, researchers analyzed blood samples from six Juul users who were asked to puff on their device every 20 seconds for 10 minutes (a total of 30 puffs). “The Juul users we studied obtained blood nicotine concentrations almost three times as high as most of the e-cigarette users we previously studied,” said Jessica Yingst, a research project manager. 

When the research participants were also asked to rate their withdrawal symptoms and other effects like ni

cotine craving and anxiety before and after vaping, they reported higher levels of nicotine dependence than more than 3,000 long-term users of other e-cigarettes. “In previous studies, we found that e-cigarette users were less addicted than smokers. However, the high nicotine delivery of the product and the scores on this study suggest that Juul is probably as addictive as 

cigarettes,” said study co-author Jonathan Foulds, a professor of public health sciences.

Following this, according to interviews with over a dozen tobacco researchers, pediatricians and Reuters review of Juul patents and nicotine chemistry, “the breakthrough “nicotine salts” formula that made the Juul e-cigarette so addictive – and ignited the company’s explosive market-share growth – made Juul especially attractive to teenagers and other new users who otherwise would never have smoked cigarettes. 

Teens Seduced by Smooth Flavors and ‘Smoke Rings’

CDC research reveals two thirds of teens weren’t even aware Juul contained nicotine 

With the latest figures showing that two thirds of Juul users aged 15-24 didn’t always know that Juul contained nicotine, it’s no wonder why there’s concern around youth addiction and vaping-related illnesses, especially as young users continue to post photos or videos of themselves performing smoke stunts or smoking multiple Juul’s on social media, often tagged under the hashtags such as #juullife or #doit4juul. 

In the latest available data from the CDC in September 2019, it shows that more than one in four high schoolers – 27.5% – reported using e-cigarettes in the previous month, a figure that’s consistently kept climbing month after month, despite the growing public concern about the product. 

In an effort to try and curb youth addiction and usage, Juul recently stopped selling its best-selling Mint flavored pods at the beginning of November. The company’s surprise announcement came just weeks after it pulled the popular Mango, Creme, Fruit and Cucumber flavors from the shelves in October. 

Juul now only sells its Menthol, Classic Tobacco and Virginia Tobacco varieties, but there’s still cause for concern that teens will shift from Mint to Menthol. Studies published in the medical journal JAMA found that nearly 60% of high school students who vape use Juul, and mint was the most popular flavor among US 10th and 12th graders.

The Repercussions of a Youth Epidemic 

Vaping death toll hits 42, with 2,100+ cases reported nationwide 

Sadly, with the latest figures from the CDC revealing that 42 deaths and 2,172 vaping-related injury cases have been reported in addition to figures of American youths  addicted to nicotine reportedly reaching more than 5 million, it is clear this is an epidemic that is not going away any time soon.

If you or a loved one has been affected by Juul addiction or injury, we’re here for you. 

We are currently investigating cases where an individual has used JUUL for at least three months and developed:

Lung Injuries 

Heart Injuries 

Addiction

Alternative Injuries

Or has had a stroke or seizure

Do I Have a Case?  

If you or a loved one has been diagnosed with a severe lung disease such as Bronchioloitis Obliterans or pneumonia, suffered a heart attack, seizure, or stroke, or developed a nicotine addiction after the use of a JUUL e-cigarette product, please reach out to the Minnesota e-cigarette lawyers at GoldenbergLaw.  We will guide you through the legal process and fight to get you fair compensation. GoldenbergLaw delivers the gold standard advocacy you deserve.